Joint device and method

ABSTRACT

Further, a method of treating hip joint osteoarthritis in a human patient by providing an artificial hip joint surface using a mold is provided. The method comprises the steps of: said mold being placed inside of said hip joint, said mold being injected with a fluid adapted to harden, said fluid hardening inside of said hip joint, said mold being resorbed by the human body, and said hardened fluid serving as artificial hip joint surface.

This application is a continuation of U.S. application Ser. No.13/383,293, filed on 10 Jan. 2012, which is the U.S. national phase ofInternational Application No. PCT/SE2010/050819, filed 12 Jul. 2010,which designated the U.S. and claims the benefit of U.S Provisional Nos.61/229,730 filed 30 Jul. 2009; 61/229,731 filed 30 Jul. 2009; 61/229,733filed 30 Jul. 2009; 61/229,735 filed 30 Jul. 2009; 61/229,738 filed 30Jul. 2009; 61/229,739 filed 30 Jul. 2009; 61/229,743 filed 30 Jul. 2009;61/229,745 filed 30 Jul. 2009; 61/229,746 filed 30 Jul. 2009; 61/229,747filed 30 Jul. 2009; 61/229,748 filed 30 Jul. 2009; 61/229,751 filed 30Jul. 2009; 61/229,752 filed 30 Jul. 2009; 61/229,755, filed 30 Jul.2009; 61/229,761 filed 30 Jul. 2009; 61/229,767 filed 30 Jul. 2009;61/229,778 filed 30 Jul. 2009; 61/229,786 filed 30 Jul. 2009; 61/229,789filed 30 Jul. 2009; 61/229,796 filed 30 Jul. 2009; 61/229,802 filed 30Jul. 2009; 61/229,805 filed 30 Jul. 2009; 61/229,811 filed 30 Jul. 2009;61/229,815 filed 30 Jul. 2009; 61/229,816 filed 30 Jul. 2009; and whichclaims priority to Swedish Application Nos.: 0900981-2 filed 10 Jul.2009; 0900957-2 filed 10 Jul. 2009; 0900958-0 filed 10 Jul. 2009;0900959-8 filed 10 Jul. 2009; 0900960-6 filed 10 Jul. 2009; 0900961-4filed 10 Jul. 2009; 0900962-2 filed 10 Jul. 2009; 0900963-0 filed 10Jul. 2009; 0900964-8 filed 10 Jul. 2009; 0900965-5 filed 10 Jul. 2009;0900966-3 filed 10 Jul. 2009; 0900967-1 filed 10 Jul. 2009; 0900968-9filed 10 Jul. 2009; 0900969-7 filed 10 Jul. 2009; 0900970-5 filed 10Jul. 2009; 0900971-3 filed 10 Jul. 2009; 0900972-1 filed 10 Jul. 2009;0900973-9 filed 10 Jul. 2009; 0900974-7 filed 10 Jul. 2009; 0900975-4filed 10 Jul. 2009; 0900976-2 filed 10 Jul. 2009; 0900977-0 filed 10Jul. 2009; 0900978-8 filed 10 Jul. 2009; 0900979-6 filed 10 Jul. 2009;0900980-4 filed 10 Jul. 2009 and PCT/SE2009/000502 filed 24 Nov. 2009,the entire contents of each of which are hereby incorporated byreference.

FIELD OF INVENTION

The present invention relates generally to a medical device forimplantation in a joint, and a method of providing said medical device.

BACKGROUND

Joint osteoarthritis is a syndrome in which low-grade inflammationresults in pain in the joints, caused by abnormal wearing of thecartilage that acts as a cushion inside if the joint. This abnormalwearing of the cartilage also results in a decrease of the jointslubricating fluid called synovial fluid. Joint osteoarthritis isestimated to affect 80% of all people over 65 years of age, in more orless serious forms.

The present treatment for joint osteoarthritis comprises NSAID drugs,local injections of hyaluronic acid or glucocorticoid to helplubricating the joint, and replacing parts of the joint with aprosthesis through orthopedic surgery.

The replacing of parts of the joint is one of the most common surgeriesto date performed at hundreds of thousands of patients in the worldevery year. The most common method comprises placing a metal prosthesisin Femur and a plastic bowl in acetabulum. This operation is usuallydone through a lateral incision in the hip and upper thigh and through,fascia lata and the lateral muscles of the thigh. To get access to thehip joint, the supporting hip joint capsule attached to femur and Iliumof pelvis needs to be penetrated, making it difficult to get a fullyfunctional joint after the surgery. Femur is then cut at the neck with abone saw and the prosthesis is placed in femur either with bone cementor without. Acetabulum is slightly enlarged using an acetabular reamer,and the plastic bowl is positioned using screws or bone cement.

The surgery typically requires one week of hospitalization due to theincreased risk of infection. The recovery process is on average about 6weeks, but even after this period the patient should not perform anyphysical activates that places large strain on the joint.

Conventional orthopedic surgery has drawbacks in that it is highlyinvasive, which damages the ligaments, tendons and surrounding tissuesuch that they are weakened. Some of the ligaments surrounding thejoints, such as the ligaments of the hip and knee joint capsules neverfully regain their strength once they are severed, resulting in thepatient getting a limited motion range and/or load carrying capability.The large incisions are needed since the prosthetic parts usually are ofconsiderable size and needs to be placed in contact with the jointthrough the incision. Making a large incision creates a large surfaceexposed to the threat of bacterial and/or viral infections and extendsthe needed hospital stay.

SUMMARY

A mould adapted to be introduced into a joint of a human patient forresurfacing at least one carrying contacting surface of the joint isprovided. The mould is adapted to receive material for resurfacing atleast one carrying contacting surface of the joint. The mould comprisesa mould material adapted to be affected by a fluid injected into saidmould such that said mould melts or is resorbed by the human body afterhaving served its purpose.

According to one embodiment the mould comprises a hyaluronan-basedmaterial, in which case the mould could be adapted to receivehyaluronidase, and wherein the material of said mould is affected by theinjection of the hyaluronidase such that the mould melts or is resorbedfaster than without the injection of the hyaluronidase.

According to one embodiment the mould comprises a fibrin-based material,in which case the mould could be adapted to receive plasmin, and whereinthe material of said mould is affected by the injection of the plasminsuch that the mould melts or is resorbed faster than without theinjection of the plasmin.

According to one embodiment the mould comprises a collagen-basedmaterial, in which case the mould could be adapted to receivecollagenase, and wherein the material of said mould is affected by theinjection of the collagenase such that the mould melts or is resorbedfaster than without the injection of the collagenase.

According to one embodiment the mould comprises a chitosan-basedmaterial, in which case the mould could be adapted to receive lysozyme,and wherein the material of said mould is affected by the injection ofthe lysozyme such that the mould melts or is resorbed faster thanwithout the injection of the lysozyme.

In any of the embodiment herein, the mould material could be adapted tobe melted by the temperature of the received material.

The received material could in any of the embodiment herein comprise atleast one material selected from the group consisting of:polytetrafluoroethylene, perfluoroalkoxy, fluorinated ethylenepropylene, polyethylene, and acrylic polymer mixed with aluminatrihydrate.

According to one embodiment, the mould could be adapted to be melted bythe received material having a temperature in the interval 40-60 degreesCelsius, or in the interval 60-90 degrees Celsius, or in the interval90-200 degrees Celsius, or in the interval 200-400 degrees Celsius ormore than 400 degrees Celsius.

According to yet another embodiment, the mould could be collapsible suchthat said mould can be introduced into the hip joint through a hole inany of: the pelvic bone, the femoral bone and the hip joint capsule.

According to yet another embodiment, the mould could be collapsible suchthat said mould can be introduced into the knee joint through a hole inany of: the femoral bone, the tibia bone and the knee joint capsule.

The mould according to any one of the embodiments could further comprisean injecting entrance in said mould adapted to receive injected materialinto said mould.

A mould adapted to be introduced into a joint of a human patient forresurfacing at least one carrying contacting surface of the joint isfurther provided. The mould is adapted to receive material forresurfacing at least one carrying contacting surface of the joint. Themould comprises a first material adapted to enclose a second materialinjected into said mould, the first and said second material is the samematerial, such that the first and said second material forms asubstantially homogenous material for resurfacing at least one carryingcontacting surface of the joint.

The mould could according to one embodiment be collapsible such that themould can be introduced into the hip joint through a hole in any of: thepelvic bone, the femoral bone and the hip joint capsule.

According to yet another embodiment, the mould could be collapsible suchthat the mould can be introduced into the knee joint through a hole inany of: the femoral bone, the tibia bone and the knee joint capsule.

The mould could further comprising an injecting entrance in said mouldadapted to receive injected material into said mould.

The first and second material in any of the embodiments could comprise amaterial selected from the group consisting of: polytetrafluoroethylene,perfluoroalkoxy, fluorinated ethylene propylene, polyethylene, andacrylic polymer mixed with alumina trihydrate.

A system comprising the mould according to any one of the precedingembodiments, and an injecting member in connection with said mould,adapted to inject a fluid into said mould is further provided.

The injecting member comprises at least one container, a fluid conduit,and a fluid injecting element adapted to be in connection with saidmould.

According to one embodiment, the fluid injecting member could comprisetwo containers, and wherein the first and the second containers could beadapted to hold different fluids.

According to yet another embodiment, the injecting member furthercomprises a mixing unit adapted to mix said fluids contained in said twocontainers.

According to yet another embodiment, the system further comprises atleast two different fluids each adapted to be contained within one ofsaid two containers, wherein one of said two fluids is adapted to act ascatalyzing agent.

The system could further comprises a fluid adapted to be injected intosaid mould, wherein said fluid is adapted to cure and change from afluid to fixed form. The fluid could be adapted to be cured by UV-lightor by a gas serving as catalyzing agent.

The injecting member could according to one embodiment comprise at leastone bent portion, which could be bent at an adjustable angle.

According to yet another embodiment, the system could further comprise aheating element adapted to heat said container for heating the fluidcontained therein.

According to yet another embodiment, the heating element could beadapted to heat the fluid to a temperature in the interval 40-60 degreesCelsius, or in the interval 60-90 degrees Celsius, or in the interval90-200 degrees Celsius, or in the interval 200-400 degrees Celsius ormore than 400 degrees Celsius.

According to yet another embodiment, the system further comprises aradiation source adapted to radiate said container for sterilizing thefluid contained therein.

According to yet another embodiment, the fluid comprises at least oneantibacterial substance, wherein said material adapted to be injectedinto said mould is held sterile by said at least one antibacterialsubstance. In other embodiments, the container has antibacterial innersurfaces, adapted to be in contact with said fluid.

In any of the embodiments herein, the device or system could be adaptedto receive a fluid material having a melting point in the interval 40-60degrees Celsius, or in the interval 60-90 degrees Celsius, or in theinterval 90-200 degrees Celsius, or in the interval 200-400 degreesCelsius or more than 400 degrees Celsius.

The fluid in any of the embodiments herein could comprise at least onematerial selected from the group consisting of: polytetrafluoroethylene,perfluoroalkoxy, fluorinated ethylene propylene, polyethylene, andacrylic polymer mixed with alumina trihydrate.

A medical device for providing a joint surface is further provided. Themedical device could comprise a mould adapted to be introduced into ajoint of the patient, and a material adapted to cure within said mouldfor resurfacing at least one carrying contacting surface of the joint.The mould could comprise a mould material adapted to be affected by thematerial adapted to cure within said mould, such that said mould meltsor is resorbed by the human body after having served its purpose.

The medical device could be adapted for resurfacing at least one of: thehip joint caput femur surface, the hip joint acetabulum surface, thefemoral knee joint surface, and the tibia knee joint surface. Thematerial adapted to cure could comprise at least one material selectedfrom the group consisting of: polytetrafluoroethylene, perfluoroalkoxy,fluorinated ethylene propylene, polyethylene, and acrylic polymer mixedwith alumina trihydrate.

A method of providing an artificial hip joint surface using a mould isfurther provided. The method comprises the steps of: the mould beingplaced inside of the hip joint, the mould being injected with a fluidadapted to cure, the fluid curing inside of the hip joint, the mouldbeing affected by a fluid injected into said mould, the mould beingresorbed by the human body or melted by the injected material, and thefluid adapted to cure serving as artificial hip joint surface.

A method of providing an artificial knee joint surface using a mould isfurther provided, the method comprises the steps of: the mould beingplaced inside of the knee joint, the mould being injected with a fluidadapted to cure, the fluid curing inside of the knee joint, the mouldbeing affected by a fluid injected into said mould, the mould beingresorbed by the human body or melted by the injected material, and thefluid adapted to cure serving as artificial knee joint surface.

The methods could further comprise the step of heating said fluid to atemperature of more than 40 degrees Celsius for transforming said fluidfrom a solid to a fluid, and said injected fluid transforming to a solidwhen received in said mould, or heating said fluid to a temperature ofmore than 60 degrees Celsius for transforming said fluid from a solid toa fluid, and said injected fluid transforming to a solid when receivedin said mould, or heating said fluid to a temperature of more than 90degrees Celsius for transforming said fluid from a solid to a fluid, andsaid injected fluid transforming to a solid when received in said mould,or heating said material to a temperature of more than 200 degreesCelsius for transforming said material into a fluid, or heating saidfluid to a temperature of more than 400 degrees Celsius for transformingsaid fluid from a solid to a fluid, and said injected fluid transformingto a solid when received in said mould.

According to one embodiment, the step of placing the mould into the hipjoint comprises the step of introducing the mould through a hole in thepelvic bone or a hole in the femoral bone or a hole in the hip jointcapsule. Or the step of placing said mould into the knee joint comprisesthe step of introducing said mould through a hole in the femoral bone ora hole in the tibia bone or a hole in the knee joint capsule.

A method for treating hip joint osteoarthritis in a human patient byproviding at least one hip joint surface is further provided. The hipjoint comprises a caput femur and an acetabulum. The method comprisingthe steps of: cutting the skin of the human patient, dissecting an areaof the pelvic bone on the opposite side from the acetabulum, creating ahole in said dissected area, said hole passing through the pelvic boneand into the hip joint of the human patient, placing a mould between theacetabulum and the caput femur, and injecting material into said mouldfor providing at least one hip joint surface.

The mould could be resorbable or adapted to melt by the material beingheated.

According to one embodiment, the step of cutting the skin of the humanpatient could be performed in the abdominal wall of the human patient.According to another embodiment, the step of dissecting an area of thepelvic bone comprises dissecting in at least one of the following areas:the abdominal cavity, an area between peritoneum and the pelvic bone,the pelvic area, and the inguinal area.

A method for resurfacing at least one carrying contacting surface of ahip joint of a human patient is further provided. The hip jointcomprising an acetabulum and a caput femur having contacting carryingsurfaces carrying weight in the hip joint, the method comprising thesteps of: inserting a needle or a tube like instrument into thepatient's hip joint, using the needle or tube like instrument to fillthe hip joint with a fluid, placing at least one arthroscopic camera andat least one instrument in the patient's hip joint, introducing a mouldpassing into the hip joint, placing a mould between the acetabulum andthe caput femur, and said mould being injected with a fluid adapted tocure, said fluid curing inside of the hip joint, said mould beingaffected by a fluid injected into said mould, said mould being resorbedby the human body or melted by the injected material, and said fluidadapted to cure serving as artificial hip joint surface.

A method for resurfacing at least one carrying contacting surface of ahip joint of a human patient is further provided, the hip jointcomprising an acetabulum and a caput femur having contacting carryingsurfaces carrying weight in the hip joint, the method comprising thesteps of: inserting a needle or a tube like instrument into thepatient's abdomen, using the needle or tube like instrument to fill theabdomen with a gas, placing at least two laparoscopic trocars in thepatient's abdomen, inserting a camera through one of the laparoscopictrocars into the patient's abdomen, inserting at least one dissectingtool through one of said at least two laparoscopic trocars, dissectingan area of the pelvic bone on the opposite side from the acetabulum,creating a hole in said dissected area, said hole passing through thepelvic bone and into the hip joint of the human patient, introducing amould passing into the hip joint, placing said mould between theacetabulum and the caput femur, the mould being injected with a fluidadapted to cure, said fluid curing inside of the hip joint, said mouldbeing affected by a fluid injected into said mould, said mould beingresorbed by the human body or melted by the injected material, and saidfluid adapted to cure serving as artificial hip joint surface.

A method for resurfacing at least one carrying contacting surface of aknee joint of a human patient is further provided. The knee jointcomprises the femoral bone and the tibia bone having contacting carryingsurfaces carrying weight in the knee joint, the method comprising thesteps of: inserting a needle or a tube like instrument into thepatient's knee joint, using the needle or tube like instrument to fillthe knee joint with a fluid, placing at least one arthroscopic cameraand at least one instrument in the patient's knee joint, introducing amould passing into the knee joint, placing a mould between the femoralbone and the tibia bone, injecting said mould with a fluid adapted tocure, said fluid curing inside of the hip joint, said mould beingaffected by a fluid injected into said mould, said mould being resorbedby the human body or melted by the injected material, and said fluidadapted to cure serving as artificial hip joint surface.

A method for resurfacing at least one carrying contacting surface of aknee joint of a human patient is further provided. The knee jointcomprises the femoral bone and the tibia bone having contacting carryingsurfaces carrying weight in the knee joint, the method comprises thesteps of: inserting a needle or a tube like instrument into thepatient's knee joint, using the needle or tube like instrument to fillthe knee joint with a gas, placing at least one arthroscopic camera andat least one surgical instrument in the patient's knee joint, dissectingan area of the tibia bone, creating a hole in said dissected area, saidhole passing through the tibia bone and into the knee joint of the humanpatient, introducing a mould through said hole passing into the kneejoint, placing said mould between the femoral bone and the tibia bone,injecting said mould with a fluid adapted to cure, said fluid curinginside of the knee joint, said mould being affected by a fluid injectedinto said mould, said mould being resorbed by the human body or meltedby the injected material, and said fluid adapted to cure serving asartificial knee joint surface.

Another object is to provide a mould adapted to be introduced into ajoint of a human patient for resurfacing carrying contacting surfaces ofsaid joint. The mould is adapted to receive material for resurfacing thecarrying contacting surfaces of the joint. Furthermore the mould isadapted to be resorbed by the human body or melt after having served itspurpose. The injecting of a material enables a less invasive procedureof resurfacing carrying contacting surfaces of said joint.

According to one embodiment the mould further comprises an injectingmember in connection with the mould and adapted to inject material intothe mould.

According to one embodiment the mould is adapted to be introduced intothe hip joint through a hole. The hole could be placed in at least oneif: the pelvic bone, the femoral bone and the hip joint capsule.

According to one embodiment the mould according to any of theembodiments above comprises a biocompatible material adapted to beresorbed by the human body, such as a collagen type of substance.According to other embodiments the biocompatible material is adapted tobe melted by the injected substance.

The mould according to any of the embodiments herein could furthercomprise an injecting entrance in said mould being adapted to receiveinjected material into the mould.

Injecting Member

According to one embodiment the mould comprises injecting member adaptedto inject material into a mould. The injecting member could comprise atleast one container, a material injecting member in connection with themould and a material driving member in connection with the materialinjecting member.

According to one embodiment the injecting member adapted to injectmaterial into the mould, further comprises a second container. The firstand second containers could be adapted to hold different fluids. In theembodiment where the injecting member comprises a second container it isconceivable that the injecting member further comprises a mixing unitadapted to mix the fluids contained in said two containers.

The fluid is preferably adapted to harden after the injecting into themould, either on its own or by use of a catalyzing agent. In the casewhere the injecting member comprises two different fluids, one of thefluids could be adapted to act as catalyzing agent. It is furthermoreconceivable that the material or fluid is adapted to harden usingUV-light, radiation, catalysing gas or thermal change.

System

A second aspect is a system for treating osteoarthritis in a hip joint.The system comprises a mould adapted to be introduced into a joint of ahuman patient for resurfacing at least one carrying contacting surfaceof the hip joint. The mould is adapted to receive material forresurfacing at least one carrying contacting surface of the hip joint,and the mould is adapted to be resorbed by the human body or melt afterhaving served its purpose. The system also comprises an injecting memberin connection with the mould and adapted to inject material into themould. According to another embodiment the injecting member adapted toinject material into the mould is further adapted to be bent. Theinjecting member could be bent using a fixed angle, an adjustable angle,a parallel displaced part or section, or a flexible part or section.

The fluid or material adapted to be injected into the mould in the hipor knee joint is preferably kept sterile. This could be done by means ofheat, radiation, antibacterial substances, or antibacterial surfaces.The mould could be adapted to be introduced into the knee joint througha hole in the femoral bone, into the knee joint through a hole in thetibia bone or into the knee joint through a hole in the knee jointcapsule.

The mould according to any of the embodiments herein could further beadapted to be resorbed by the human body within one to six months orsubstantially resorbed by the human body within 6-8 weeks.

According to one embodiment the mould is adapted to be melted at 40degrees Celsius or higher, according to a second embodiment the mould isadapted to be melted at 60 degrees Celsius or higher, according to athird embodiment the mould is adapted to be melted at 90 degrees Celsiusor higher, according to a fourth embodiment the mould is adapted to bemelted at 200 degrees Celsius or higher, and according to a fifthembodiment the mould is adapted to be melted at 400 degrees Celsius orhigher.

According to one embodiment the system is adapted to be used inconnection with the hip joint, and in another embodiment the system isadapted to be used in connection with the knee joint.

According to one embodiment the material is adapted to be injected as afluid and further adapted to become fixed form, when received into themould, and the material becomes a fluid at a temperature of more than 40degrees Celsius. According to yet another embodiment the materialbecomes fluid at a temperature of more than 60 degrees Celsius.According to yet another embodiment the material becomes fluid at atemperature of more than 90 degrees Celsius. According to yet anotherembodiment the material becomes fluid at a temperature of more than 200degrees Celsius. According to yet another embodiment the materialbecomes fluid at a temperature of more than 400 degrees Celsius.

The medical device according to any of the embodiments could comprise atleast one material selected from a group consisting of:polytetrafluoroethylene, perfluoroalkoxy and fluorinated ethylenepropylene. It is furthermore conceivable that the material comprises ametal alloy, such as cobolt-chromium or titanium or stainless steel, orpolyethylene, such as crosslinked polyethene or gas sterilizedpolyethene. The use of ceramic material is also conceivable, in thecontacting surfaces or the entire medical device such as zirconiumceramics or alumina ceramics. According to one embodiment the medicaldevice comprises a hydroxy-apatite coating.

In other embodiments the medical device could comprise fluoropolymerresins, Kevlar and/or acrylic polymer mixed with alumina trihydrate.

Method

A method for resurfacing at least one carrying contacting surface of aknee joint of a human patient is further provided. The knee jointcomprising the femoral bone and the tibia bone having contactingcarrying surfaces carrying weight in the knee joint, the methodcomprises the steps of: creating a hole passing into the knee joint,placing a mould between the femoral bone and the tibia bone, andinjecting material into said mould for replacing and resurfacing atleast one of said carrying contacting surfaces of the knee joint.

According to one embodiment the method further comprises the step of themould being melted by the injected material, and/or resorbed by thehuman body.

According to one embodiment the method further comprises the step ofheating the material to a temperature of more than 40 degrees Celsiusfor transforming said material into a fluid, and the injected fluidmaterial transforming to a fixed form when received in said mould.

According to another embodiment the method further comprises the step ofheating the material to a temperature of more than 60 degrees Celsiusfor transforming said material into a fluid, and the injected fluidmaterial transforming to a fixed form when received in said mould.

According to yet another embodiment the method further comprises thestep of heating the material to a temperature of more than 90 degreesCelsius for transforming said material into a fluid, and the injectedfluid material transforming to a fixed form when received in said mould.

According to yet another embodiment the method further comprises thestep of heating the material to a temperature of more than 200 degreesCelsius for transforming said material into a fluid, and the injectedfluid material transforming to a fixed form when received in said mould.

According to yet another embodiment the method further comprises thestep of heating the material to a temperature of more than 60 degreesCelsius for transforming said material into a fluid, and the injectedfluid material transforming to a fixed form when received in said mould.

According to one embodiment of the method, the mould is adapted to beintroduced into the hip joint through a hole in the pelvic bone,according to another embodiment the mould is adapted to be introducedinto the hip joint through a hole in the femoral bone and according to athird embodiment the mould is adapted to be introduced into the hipjoint through a hole in the hip joint capsule.

According to another embodiment of the method, the mould is adapted tobe introduced into the knee joint through a hole in the femoral bone,the tibia bone or knee joint capsule.

A third aspect is a method for resurfacing at least one carryingcontacting surface of a hip joint of a human patient. The hip jointcomprises an acetabulum and a caput femur. The method comprises thesteps of: creating a hole passing into said hip joint, placing a mouldbetween the acetabulum and the caput femur, and injecting material intothe mould for resurfacing the carrying contacting surfaces of the hipjoint.

The method could also be a method for treating hip joint osteoarthritisin a human patient by providing at least one hip joint surface. The hipjoint comprising a caput femur and an acetabulum. The method comprisingthe steps of: cutting the skin of the human patient, dissecting an areaof the pelvic bone on the opposite side from the acetabulum, creating ahole in the dissected area, the hole passing through the pelvic bone andinto the hip joint of the human patient. Further, the method comprisesthe steps of: placing a mould between the acetabulum and the caputfemur, and injecting material into the mould providing at least one hipjoint surface.

According to a one embodiment the methods above could further comprisethe step of the mould being resorbed by the human body.

In a different embodiment the mould is adapted to be melted by thematerial being heated.

A method for treating hip joint osteoarthritis in a human patient byproviding at least one knee joint surface is further provided. The kneejoint comprises a femoral bone and a tibia platform. The methodcomprises the steps of: cutting the skin of the human patient,dissecting an area of the femoral bone, creating a hole in the dissectedarea passing through the femoral bone and into the knee joint of thehuman patient, placing a mould between the femoral bone and the tibiaplatform, and injecting material into the mould providing at least oneknee joint surface. The mould of the method could according to oneembodiment be resorbable or adapted to melt by said material beingheated.

A further method of treating hip joint osteoarthritis in a human patientby providing at least one knee joint surface is provided. The knee jointcomprises a femoral bone and a tibia platform, the method comprising thesteps of: cutting the skin of the human patient, creating a hole in thedissected area, the hole passing through the tibia bone and into theknee joint of the human patient, placing a mould between the femoralbone and the tibia platform, and injecting material into said mouldproviding at least one knee joint surface. The mould could be adapted tobe resorbable or adapted to melt when heated.

A further method of treating hip joint osteoarthritis in a human patientis provided. The knee joint comprises a femoral bone and a tibiaplatform, the method comprising the steps of: cutting the skin of thehuman patient, creating a hole in said dissected area, said hole passingthrough the knee joint capsule and into the knee joint of the humanpatient, placing a mould between the femoral bone and the tibiaplatform, and injecting material into the mould providing at least oneknee joint surface. The mould could be adapted to be resorbable oradapted to melt when heated.

A method for resurfacing at least one carrying contacting surface of ahip joint of a human patient, said hip joint comprising an acetabulumand a caput femur having contacting carrying surfaces carrying weight inthe hip joint, the method comprising the steps of: inserting a needle ora tube like instrument into the patient's hip joint, using the needle ortube like instrument to fill the hip joint with a fluid, placing atleast one arthroscopic camera and at least one instrument in thepatient's hip joint, introducing a mould passing into the hip joint,placing a mould between the acetabulum and the caput femur, andinjecting material into said mould for replacing and resurfacing atleast one of said carrying contacting surfaces of the hip joint.

Furthermore a method of resurfacing at least one carrying contactingsurface of a hip joint of a human patient is provided. The knee jointcomprising the femoral bone and the tibia bone having contactingcarrying surfaces carrying weight in the knee joint, the methodcomprising the steps of: inserting a needle or a tube like instrumentinto the patient's knee joint, using the needle or tube like instrumentto fill the knee joint with a fluid, placing at least one arthroscopiccamera and at least one instrument in the patient's knee joint,introducing a mould passing into the knee joint, placing a mould betweenthe femoral bone and the tibia bone, and injecting material into themould for replacing and resurfacing at least one of the carryingcontacting surfaces of the knee joint.

A further method for resurfacing at least one carrying contactingsurface of a knee joint of a human patient is provided. The knee jointcomprising the femoral bone and the tibia bone having contactingcarrying surfaces carrying weight in the knee joint, the methodcomprising the steps of: inserting a needle or a tube like instrumentinto the patient's knee joint, using the needle or tube like instrumentto fill the knee joint with a gas, placing at least one arthroscopiccamera and at least one surgical instrument in the patient's knee joint,dissecting an area of the tibia bone, creating a hole in the dissectedarea, the hole passing through the tibia bone and into the knee joint ofthe human patient, introducing a mould through said hole passing intothe hip joint, placing the mould between the femoral bone and the tibiabone, and injecting material into the mould for providing at least oneknee joint surface. The mould according to any of the embodiments hereincould be adapted to be resorbable or adapted to melt when by the contactwith the injected material.

The joint surface could comprise at least one artificial femoral surfaceor at least one artificial tibia surface. The medical device accordingto any of the embodiments could comprise at least one material selectedfrom a group consisting of: polytetrafluoroethylene, perfluoroalkoxy andfluorinated ethylene propylene. It is furthermore conceivable that thematerial comprises a metal alloy, such as cobalt-chromium or titanium orstainless steel, or polyethylene, such as crosslinked polyethylene orgas sterilized polyethylene. The use of ceramic material is alsoconceivable, in the contacting surfaces or the entire medical devicesuch as zirconium ceramics or alumina ceramics. According to oneembodiment the medical device comprises a hydroxy-apatite coating.

In other embodiments the medical device could comprise fluoropolymerresins, Kevlar and/or acrylic polymer mixed with alumina trihydrate.

In any of the methods above the step of cutting the skin of said humanpatient could be performed in the abdominal wall of the human patient.The step of dissecting an area of the pelvic bone could comprisesdissecting in at least one of the following areas: the abdominal cavity,an area between peritoneum and the pelvic bone, the pelvic area, and theinguinal area.

According to yet another embodiment, a method for treating hip jointosteoarthritis in a human patient by providing at least one hip jointsurface is provided. The hip joint comprising a caput femur and anacetabulum. The method could comprise the steps of: cutting the skin ofsaid human patient, creating a hole in the dissected area, the holepasses through the femoral bone and into the hip joint of the humanpatient. The method further comprises the steps of: placing a mouldbetween the acetabulum and the caput femur, and injecting material intothe mould providing at least one hip joint surface.

According to yet another embodiment, a method of treating hip jointosteoarthritis in a human patient by providing at least one hip jointsurface is provided. The hip joint comprises a caput femur and anacetabulum. The method comprises the steps of: cutting the skin of saidhuman patient, creating a hole in said dissected area, said hole passingthrough the hip joint capsule and into the hip joint of the humanpatient. Whereafter a mould is placed between said acetabulum and saidcaput femur, material is injected into said mould providing at least onehip joint surface.

According to yet another embodiment, a method for treating a hip jointof a human patient by providing at least one hip joint surface isprovided. The hip joint comprises a caput femur and an acetabulum. Themethod comprises the steps of: inserting a needle or a tube likeinstrument into the patient's body, using the needle or tube likeinstrument to fill an area of the hip joint with gas thereby expanding acavity, placing at least two laparoscopic trocars in the patient's body,inserting a camera through one of the laparoscopic trocars into thepatient's abdomen, inserting at least one dissecting tool through one ofthe at least two laparoscopic trocars, dissecting an area of the pelvicbone on the opposite side from said acetabulum. Whereafter the methodcomprises the steps of: creating a hole in the dissected area, the holepassing through said pelvic bone and into said hip joint of said humanpatient, placing a mould between said acetabulum and said caput femur,and injecting material into said mould for providing at least one hipjoint surface.

According to yet another embodiment a method for treating a hip joint ofa human patient by providing at least one hip joint surface is provided.The hip joint comprises a caput femur and an acetabulum, the methodcomprises the steps of: inserting a needle or a tube like instrumentinto the patient's body, using the needle or tube like instrument tofill an area of the hip joint with gas thereby expanding a cavity,placing at least two laparoscopic trocars in the patient's body,inserting a camera through one of the laparoscopic trocars into thepatient's body, inserting at least one dissecting tool through one ofthe at least two laparoscopic trocars, dissecting an area of the hipjoint, creating a hole in the dissected area, said hole passing throughthe femoral bone and into the hip joint of the human patient, placing amould between the acetabulum and the caput femur, and injecting materialinto the mould for providing at least one hip joint surface.

According to yet another embodiment a method for treating a hip joint ofa human patient by providing at least one hip joint surface is provided.The hip joint comprises a caput femur and an acetabulum. The methodcomprises the steps of: inserting a needle or a tube like instrumentinto the patient's body, using the needle or tube like instrument tofill the patient's abdomen with gas thereby expanding a cavity, placingat least two laparoscopic trocars in the patient's body, inserting acamera through one of the laparoscopic trocars into the patient'sabdomen, inserting at least one dissecting tool through one of the atleast two laparoscopic trocars, dissecting an area of the hip joint,creating a hole in the dissected area, said hole passing through the hipjoint capsule and into the hip joint of said human patient, placing amould between said acetabulum and said caput femur, and injectingmaterial into said mould for providing at least one hip joint surface.

The mould in any of the embodiments above could be adapted to beresorbable or adapted to melt after having served its purpose as mould.

Medical Device

A fourth aspect concerns a medical device for treating jointosteoarthritis by providing a joint surface. The medical device is madeinside of the joint by injecting material into a mould.

According to one embodiment the medical device comprises at least oneartificial hip joint surface, which could be at least one of anartificial caput femur surface and an artificial acetabulum surface.

According to one embodiment the medical device the joint surfacecomprises at least one artificial knee joint surface.

The medical device should serve as carrying contacting joint surface andfor that purpose the medical device could comprise fluoropolymers, suchas: polytetrafluoroethylene, perfluoroalkoxy and fluorinated ethylenepropylene.

A method of treating hip joint osteoarthritis in a human patient byproviding an artificial hip joint surface using a mould is furtherprovided. The method comprises the steps of: the mould being placedinside of said hip joint, the mould being injected with a fluid adaptedto harden, the fluid hardening inside of said hip joint, the mould beingresorbed by the human body, and the hardened fluid serving as artificialhip joint surface.

A different embodiment of the method is a method of treating knee jointosteoarthritis in a human patient by providing an artificial knee jointsurface using a mould. The method comprises the steps of: the mouldbeing placed inside of said knee joint, the mould being injected with afluid adapted to harden, the fluid hardening inside of said knee joint,the mould being resorbed by the human body, and the hardened fluidserving as artificial knee joint surface.

A method of creating the medical device according to any of theembodiments above using the mould according to any of the embodimentsabove is also provided.

According to one embodiment the fluid is adapted to be injected withsuch a high temperature to affect the nerve cells in the resurfacingcontacting surface to damage the nerve cells to reduce pain.

Please note that any method or part of method may be combined with anyother method or part of method to create any combination of methods orparts of methods.

BRIEF DESCRIPTION OF DRAWINGS

The embodiments are now described, by way of example, with reference tothe accompanying drawings, in which:

FIG. 1 shows the hip joint in section,

FIG. 2 shows a lateral view of a conventional hip joint surgery,

FIG. 3 shows a lateral view of a conventional hip joint surgery,

FIG. 4a shows an anterior view of the knee joint,

FIG. 4b shows a side view of the knee joint,

FIG. 5 shows the creation of a large hole in the pelvic bone,

FIG. 6 shows the creation of a small hole in the pelvic bone,

FIG. 7 shows the creation of a hole in the femoral bone,

FIG. 8 shows the creation of a hole in the hip joint capsule,

FIG. 9 shows an instrument adapted to ream, in a first state,

FIG. 10 shows an instrument adapted to ream, in a second state,

FIG. 11 shows an instrument adapted to ream, from underneath,

FIG. 12 shows an instrument adapted to ream, when reaming,

FIG. 13 shows an arthroscopic camera being placed in a second hole inthe pelvic bone,

FIG. 14a shows an incision in the knee of a human patient, in ananterior view,

FIG. 14b shows two laparoscopic incisions in the knee of a humanpatient, in an anterior view,

FIG. 15a shows an instrument for inserting a mould,

FIG. 15b shows an instrument for inserting a mould, in section,

FIG. 15c shows an instrument for inserting a mould, comprising aflexible part or section,

FIG. 16a shows an instrument for inserting a mould,

FIG. 16b shows an instrument for inserting a mould, comprising aparallel displaced part or section,

FIG. 16c shows an instrument for inserting a mould, comprising twojoints,

FIG. 17 shows the placing of a mould in the hip joint through the pelvicbone,

FIG. 18a shows the placing of a mould in the hip joint through thefemoral bone,

FIG. 18b shows the placing of a mould in the hip joint through thefemoral bone,

FIG. 18c shows the placing of a mould in the hip joint through thefemoral bone,

FIG. 18d shows the mould in place in the hip joint,

FIG. 19 shows the placing of a mould in the knee joint,

FIG. 20 shows an instrument injecting a fluid into the mould in the kneejoint,

FIG. 21 shows an instrument injecting a fluid into the mould in the hipjoint, through the pelvic bone,

FIG. 22 shows an instrument injecting a fluid into the mould in the hipjoint, through the femoral bone,

FIG. 23 shows an instrument injecting a fluid into the mould in the hipjoint, through the hip joint capsule,

FIG. 24 shows the hip joint in section, after a fluid has been injected,

FIG. 25a shows a prosthetic part being used to close a hole in a pelvicbone,

FIG. 25b shows how sections of a prosthetic part is used as supportagainst the edges of the hole in a pelvic bone,

FIG. 25c shows the insertion of a prosthetic part in a hole in a pelvicbone,

FIG. 26a shows how screws are being used to fixate a bone plug or aprosthetic part in a hole in a pelvic bone of a human patient,

FIG. 26b shows the hip joint in section when fixation elements areplaced,

FIG. 26c shows the hip joint in section when fixation elements areplaced,

FIG. 26d shows the hip joint in section when fixation elements areplaced,

FIG. 27a shows the knee joint when an injecting member injects a fluidinto a mould,

FIG. 27b shows the knee joint when an injecting member injects a fluidinto a mould, in a laparoscopic embodiment,

FIG. 28 shows a human patient in a lateral view when an injecting memberinjects a fluid into a mould,

FIG. 29 shows an injecting member in further detail,

FIG. 30 shows an injecting member, comprising a flexible part orsection,

FIG. 31 shows an injecting member, comprising two joints.

DETAILED DESCRIPTION

Before the present invention is described, it is to be understood thatthe terminology employed herein is used for the purpose of describingparticular embodiments only and is not intended to be limiting, sincethe scope of the present invention will be limited only by the appendedclaims and equivalents thereof.

It must be noted that, as used in this specification and the appendedclaims, the singular forms “a,” “an,” and “the” include plural referentsunless the context clearly dictates otherwise.

Also, the term “about” is used to indicate a deviation of +/−2% of thegiven value, preferably +/−5%, and most preferably +/−10% of the numericvalues, where applicable.

In addition to the above, the following terms will be used:

Biocompatible material is to be understood as being a material with lowlevel of immune response. Biocompatible materials are sometimes alsoreferred to as biomaterials. Analogous is biocompatible metals a metalwith low immune response such as titanium or tantalum. The biocompatiblemetal could also be a biocompatible alloy comprising at least onebiocompatible metal.

Form fitting is to be understood as an element having a part or sectionwhich is adapted to enable a mechanical connection of said element to atleast one other element using said part or section. Form fittedstructure is a structure of an element which enables form fitting.

Elasticity is to be understood as a materials ability to deform in anelastic way.

Elastic deformation is when a material deforms under stress (e.g.external forces), but returns to its original shape when the stress isremoved. A more elastic material is to be understood as a materialhaving a lower modulus of elasticity. The elastic modulus of an objectis defined as the slope of its stress-strain curve in the elasticdeformation region. The elastic modulus is calculated as stress/strain,where stress is the force causing the deformation, divided by the areato which the force is applied; and strain is the ratio of the changecaused by the stress.

Stiffness is to be understood as the resistance of an elastic body todeformation by an applied force.

Functional hip movements are to be understood as movements of the hipthat at least partly correspond to the natural movements of the hip. Onsome occasions the natural movements of the hip joint might be somewhatlimited or altered after hip joint surgery, which makes the functionalhip movements of a hip joint with artificial surfaces somewhat differentthan the functional hip movements of a natural hip joint.

The functional position of an implantable medical device or prosthesisis the position in which the hip joint can perform functional hipmovements.

Functional hip joint is a hip joint that can perform functional hipmovements either with or without an implanted medical device orprosthesis.

The medical device according to any of the embodiments could comprise atleast one material selected from a group consisting of:polytetrafluoroethylene (PTFE), perfluoroalkoxy (PFA) and fluorinatedethylene propylene (FEP). It is furthermore conceivable that thematerial comprises a metal alloy, such as cobalt-chromium-molybdenum ortitanium or stainless steel, or polyethylene, such as cross-linkedpolyethylene or gas sterilized polyethylene. The use of ceramic materialis also conceivable, in the contacting surfaces or the entire medicaldevice such as zirconium ceramics or alumina ceramics. The part of themedical device in contact with human bone for fixation of the medicaldevice to human bone could comprise a poorhouse structure which could bea porous micro or nano-structure adapted to promote the growth-in ofhuman bone in the medical device for fixating the medical device. Theporous structure could be achieved by applying a hydroxy-apatite (HA)coating, or a rough open-pored titanium coating, which could be producedby air plasma spraying, a combination comprising a rough open-poredtitanium coating and a HA top layer is also conceivable. The contactingparts could be made of a self lubricated material such as a waxypolymer, such as PTFE, PFA, FEP, PE and UHMWPE, or a powder metallurgymaterial which could be infused with a lubricant, which preferably is abiocompatible lubricant such as a Hyaluronic acid derivate. It is alsoconceivable that the material of contacting parts or surfaces of themedical device herein is adapted to be constantly or intermittentlylubricated. According to some embodiments the parts or portions of themedical device could comprise a combination of metal materials and/orcarbon fibers and/or boron, a combination of metal and plasticmaterials, a combination of metal and carbon based material, acombination of carbon and plastic based material, a combination offlexible and stiff materials, a combination of elastic and less elasticmaterials, Corian or acrylic polymers.

In the following a detailed description of embodiments will be given. Inthe drawing figures, like reference numerals designate identical orcorresponding elements throughout the several figures. It will beappreciated that these figures are for illustration only and are not inany way restricting the scope. Thus, any references to direction, suchas “up” or “down”, are only referring to the directions shown in thefigures. Also, any dimensions etc. shown in the figures are forillustration purposes.

FIG. 1 shows the hip joint of a human patient in section. The hip jointcomprises a caput femur 5 placed at the very top of collum femur 6 whichis the top part of the femur bone 7. The caput femur is in connectionwith the acetabulum 8 which is a bowl shaped part of the pelvic bone 9.Both the caput femur surface 10 and the acetabulum surface 11 is coveredwith articular cartilage 13 which acts as a cushion in the hip joint. Inpatients with hip joint osteoarthritis, this articular cartilage 13 isabnormally worn down or often down due to a low grade inflammation. Thehip joint is surrounded by the hip joint capsule 12 which providessupport for the joint and hinders luxation. After conventional hip jointsurgery, penetrating the hip joint capsule 12, the capsule 12 isdramatically weakened due to the limited healing possibilities of itsligament tissue. By performing hip joint surgery without damaging thehip joint capsule 12 the patient can fully recover and place equalamount of strain on an artificial joint as is possible on a natural one.

FIG. 2 shows a lateral view of a conventional hip joint surgery where anincision 112 is made in the tight 113 enabling the surgeon to reach thefemur bone 7 on which the caput femur 5 is located. In a conventionalhip joint surgery the hip joint is accessed through the hip jointcapsule.

FIG. 3 shows the placing of an artificial caput femur surface 45 on thecaput femur 5 in conventional surgery.

FIG. 4a shows the knee joint J of a left knee of a human in an anteriorview. The lower extremity 211 of femur or the femoral bone 210 suppliesthe knee joint surface of the femoral bone, whereas the upper extremityof tibia 510 or the shinbone supplies the lower knee joint surface. Thelower part of the leg comprises tibia 510 or the shinbone and fibula 511or the calf bone. Furthermore FIG. 4 shows the knee joint when aresurfacing 213 of a knee joint J surface has been performed.

4 b shows the knee joint in section from the side. The condyles 105 isthe lower extremity of the femoral bone 210 and makes up the sides ofthe upper part of the knee joint. Tibia 510 or the shinbone constitutesthe lower part of the knee joint, tibia is in connection with fibula 511or the calf bone, tibia and fibula constitutes the bones of the lowerpart of the leg.

FIG. 5 shows an embodiment wherein the mould is to be used forresurfacing the hip joint. For placing the mould in the hip joint thehip joint needs to be reached, with reference to FIG. 1 this could bethrough a hole placed in the pelvic bone 9, the femoral bone 7 or thehip joint capsule 12. FIG. 5 shows the hole 18 in the pelvic bone 9according to a first embodiment, the hole 18 is large which allows themould to pass through said hole 18 in its full functional size.

FIG. 6 shows the hole 20 according to a second embodiment wherein thehole 20 created in a surgical or laparoscopic method is much smallerallowing the surgical instrument creating the hole to be smaller, andthus the incision and dissection performed in the human body. To placethe mould in the joint in this embodiment the mould needs to be flexibleor collapsible.

FIG. 7 shows the hip joint in section when creating a hole in the femurbone 7. The hole in the femur bone passes through the caput femur 5 intothe hip joint and enables the surgeon to reach the hip joint.

FIG. 8 shows the hip joint in section when creating a hole in the hipjoint capsule 12. The hole in the hip joint capsule passes into the hipjoint and enables the surgeon to reach the hip joint.

Before the introduction of a mould or material into the hip joint thehip joint surfaces could need to be prepared. This preparation could beperformed by reaming the acetabulum and/or the caput femur surface.

FIG. 9 shows a reamer according to a first embodiment wherein saidreamer is expandable. The expandable reamer comprises at least onereaming blade 40 which comprises a reaming surface 41 a,b. Saidexpandable reamer could be adapted to ream the acetabulum 8, the caputfemur 5 or both. In the embodiment where said expandable reamer isadapted to ream the acetabulum 8 said reaming surface 41 a is located onthe exterior part of the at least one reaming blade 40, whereas in theembodiment when said expandable reamer is adapted to ream the caputfemur 5, said reaming surface 41 b is located on the interior part ofthe at least one reaming blade 40. According to a second embodiment saidexpandable reamer is adapted to ream both the acetabulum and the caputfemur, in which case the reamer has reaming surfaces 41 a,b both on theexterior and the interior part of the at least one reaming blade 40.

FIG. 10 shows the expandable reamer according to the first embodimentwherein the reaming blades 40 can be folded towards a center of thesemi-sphere that the expandable reamer produces in its expanded state,shown in FIG. 15. The folding of the reaming blades 40 enables theexpandable reamer to be introduced into a hip joint through a holesmaller than the area possible to ream using said expandable reamer.

FIG. 11 shows the interior said of the expandable reamer with thereaming blades 40. In the embodiment when the expandable reamer isadapted to ream the caput femur said interior side of the at least onereaming blade 40 comprises a reaming surface 41 b.

FIG. 12 shows the expandable reamer according to any of the embodimentswhen reaming said acetabulum 8 and/or said caput femur 5. The reamer canbe adapted to be operated manually or by means of a rotating, vibratingor oscillating operating device.

To get a view inside the hip joint it is conceivable that the surgeoncan make a second hole in the pelvic bone, the femoral bone or the hipjoint capsule to insert a camera.

FIG. 13 shows the hip joint in section wherein a second hole 18 b in thepelvic bone 9 enables the surgeon to place a camera 34 into the hipjoint, preferably used in a laparoscopic method.

FIG. 14a shows the knee 214 in an anterior view and the creation of ahole passing into the knee joint J enabling the placing of a mould 81inside of the knee joint J for resurfacing the knee joint surface offemur 210 or tibia 510.

FIG. 14b shows the knee 214 in an anterior view and the creation of asmaller hole for a laparoscopic/arthroscopic method, the hole passinginto the knee joint J enabling the placing of a mould 81 inside of theknee joint J for resurfacing the knee joint surface of femur 210 ortibia 510.

After the preparation of the surfaces the mould needs to be insertedinto either the hip joint or the knee joint.

FIG. 15a shows an instrument for placing a mould 81 in the hip joint orthe knee joint through a hole in the pelvic bone, the femur bone, thehip joint capsule or an area of the knee. The instrument comprises apiston 89 for transporting the mould 81 into the joint.

FIG. 15b shows a section of the surgical instrument comprising a tubelike element 90 for housing of said mould 81.

FIG. 15c shows the surgical instrument according to another embodimentin which the surgical instrument comprises a flexible or bent part 91improving the reach of the surgical instrument. The surgical instrumentaccording to any of the embodiments can be used to place said mould 81inside of a joint in any of the ways described in the followingembodiments.

FIG. 16a shows an instrument adapted to insert the mould 81 in a hipjoint or a knee joint, according to a second embodiment. According tothis embodiment the surgical instrument comprises a gripping portion 76and a handling portion 77. According to the embodiments shown in FIG. 14a,b,c the instrument further comprises a rotation element 78 thatenables the gripping part 76 to rotate in relation to the handling part77, however it is equally conceivable that the surgical instrument lacksthis rotation element 78.

FIG. 16b shows the surgical instrument adapted to insert the mould 81 ina hip joint or a knee joint, according to a third embodiment. Accordingto this embodiment the surgical instrument further comprises a paralleldisplaced section 79, which increases the reach of the instrument andfacilitates the reaching of the hip joint through a hole in the pelvicbone, the femoral bone or the hip joint capsule.

FIG. 16c shows the surgical instrument adapted to insert the mould 81 ina hip joint, according to a third embodiment. According to thisembodiment the surgical instrument further comprises two angle adjustingmembers 80 a, b. The angle adjusting members could be adjustable forvarying the angle of said gripping part 76 in relation to the handlingportion 77, or fixed in an angle suitable for operating in a jointthrough a hole in the pelvic bone, the femur bone, the hip joint capsuleor an area of the knee joint.

FIGS. 17-24 shows the insertion and use of a mould produced from abiologically resorbable polymer film. Said mould is made to fit into theacetabular fossa and to define the shape of an acetabular cup. The mouldis sterilized and evacuated.

The sterile mould is inserted in a hip joint, and a liquid polymermixture is injected into said mould, filling said mould, whereby saidmold in its filled state takes the shape of an acetabular cup. Thepolymer mixture is cured in said mould, and retains the shape defined bysaid mould, whereupon said polymer film forming the mould is resorbed,leaving a cured polymer solid in the shape of an acetabular cup.

The biologically resorbable film is chosen from films and membranes madeof polylactide polymers, polyglycolide polymers, polycaprolactonepolymers, or lactide/glycolide copolymers, or lactide/caprolactonecellulose-based film; a hyaluronan-based film, a fibrin-based film, acollagen-based film, a chitosan-based film or combinations thereof.

A non-limiting example of a bioabsorbable membrane is the Cytoskin™membrane (Biogeneral Inc., San Diego, Calif., USA) available in athickness of 12 μm to 150 μm. Other bioabsorbable materials areexemplified by the Purasorb® product line (Purac Biomaterials,Gorinchem, The Netherlands). The Purasorb® materials can be processed byconventional processing techniques, such as extrusion, compressionmolding and injection molding, and can be subjected to differentsterilization techniques. These materials are commercially available inthe form of various resorbable orthopedic implant devices. With theadvantages of excellent biocompatibility and biodegradability they serveas the matrix in a wide variety of applications to treat injuries of themuscoskeletal system in areas such as sports medicine, trauma and spinalsurgery. Further, the properties of the Purasorb® polymers can betailored to the application to meet all the design criteria.

Clinical experience in a large number of cases shows that a lacticacid-glycolic acid copolymer is resorbed in 12-15 months incraniosynostosis surgery. It is very likely that the resorption time ina joint would be shorter, as the film will be subject to mechanicalwear.

The liquid polymer mixture is chosen from polytetrafluoroethylene,perfluoroalkoxy propylene, fluorinated ethylene propylene, polyethylene,and highly crosslinked polyethylene.

Another example of embodiment is a resorbable mould with acceleratedresporption. The biological resorption of the mould is accelerated bythe introduction of an agent taking part in, or accelerating, theresorption. When the film for example comprises a hyaluronan-basedmaterial, hyaluronidase can be added in a suitable amount, when the filmcomprises a fibrin-based material, plasmin is added in a suitableamount, when the film comprises a collagen-based material, collagenaseis added in a suitable amount, and when the film comprises achitosan-based material, lysozyme is added in a suitable amount.

Another example of embodiment is a resorbable mould with inner coating.As in the previous embodiments the mould is produced from a biologicallyresorbable polymer film, for example but not limited to the Cytoskin™membrane (Biogeneral Inc.). The inside of the mould is coated with abiocompatible compound which improves the properties of the acetabularcup, for example reduced friction, increases surface strength, reduceswear etc. A non-limiting example of such coating is a biocompatiblephospholipid polymer, 2-methacryloyloxyethyl phosphorylcholine (MPC)shown to form a hydrated lubricating layer, significantly decreasingfriction and wear, reducing the amount of wear particles compared touncoated joint surfaces.

When the mould is filled with the polymer mixture intended to form theacetabular cup, the MPC-coating will be grafted into the outer surfaceof the solid polymer, significantly reducing friction and wear. Themould itself will be resorbed through the action of natural resorptionmechanisms, or resorption mechanisms augmented through the addition ofsuitable agents, as described above, exposing the coated surface.

Another example of embodiment is a mould that melts and integrates withcore. In order to form an acetabular cup inside a hip joint, using apolymer mixture, e.g. a polymer having a melting point in the interval40-60° C., or 40-90° C., or 40-200° C., or 40 to 400° C., a mould isproduced from a polymer film, said polymer chosen from polymers havingthe same or lower melting point as said polymer.

Said mould is shaped to fit into the acetabular fossa and to define theshape and volume of an acetabular cup. The mould is sterilized andevacuated.

The mould is inserted in a hip joint, and a heated liquid polymermixture is introduced e.g. injected into said mould, the temperature ofthe liquid polymer mixture being above both the melting point of thepolymer mixture, and above the melting point of the polymer forming themould. When filling said mould, the heated polymer contacts and meltsthe film forming the mould, and seamlessly integrates with said film.

Another example of embodiment is a mould that melts and is absorbed bycore. An alternative to the examples described above is that thebiocompatible material forming the mould, and the polymer materialforming the core of the artificial acetabular cup, are chosen so thatthe material forming the mould will be resorbed by the material formingthe core. In order to achieve this, a skilled person will need to studythe melting temperature of the materials, the surface properties, chargeand other properties of the materials. The material forming the mouldand the material forming the core are chosen so that the materialforming the mould will be absorbed by the core material.

FIG. 17 shows the step of placing the mould 81 inside of the hip jointof a human patient through a hole 18 in the pelvic bone 9. The step ofplacing said mould 81 can be performed in a surgical, or in alaparoscopic/arthroscopic method.

FIG. 18 a,b,c,d shows an alternative approach to placing said mould 81in the hip joint of a human patient. Said alternative approach comprisesthe steps of creating a hole 82 in the femur bone 7 following a lengthaxis of the collum femur 6, said hole starting from the lateral side ofthe thigh, penetrating the cortex of the femur bone 7 and eventuallyreaching the cortex of the caput femur 5 from the inside thereof,penetrating said cortex and entering into the hip joint. After thecreation of the hole 82 in the femur bone 7 the mould 81 is insertedinto the hip joint through the hole 82 using the surgical instrument 83according to any of the embodiments above, as shown in FIG. 18 b.

FIG. 18c shows the mould 81 when being inserted into the hip joint usingthe surgical instrument 83 adapted therefore.

FIG. 18d shows the mould 81 in place after insertion into the hip joint,the surgical instrument used to place said mould 81 in the hip joint isretracted after the insertion is completed.

FIG. 19 shows the placing of a mould 81 in a knee 214 in a surgicalmethod. The mould 81 is placed using the surgical instrument accordingto any of the embodiments above.

FIG. 20 shows the placing of a mould 81 in a knee 214 in a laparoscopicmethod. The mould 81 is placed using the surgical instrument accordingto any of the embodiments above.

After the mould has been placed in the hip or knee joint it is filledwith a fluid adapted to harden to a medical device adapted to serve asat least one artificial joint surface.

FIG. 21 shows the hip joint in section wherein an injecting member 92injects a fluid 93 into a mould 81 in the hip joint through a hole 18 inthe pelvic bone 9 from the opposite side from acetabulum 8. Theinjecting member 92 comprises a piston 94 that pushes said fluid 93 intothe mould 81.

FIG. 22 shows the hip joint in section wherein an injecting member 92injects a fluid 93 into a mould 81 in the hip joint through a hole 82 inthe femur bone 7. The injecting member 92 comprises a piston 94 thatpushes said fluid 93 into the mould 81.

FIG. 23 shows the hip joint in section wherein an injecting memberinjects a fluid 93 into a mould 81 in the hip joint through a hole inthe hip joint capsule 12. The injecting member 92 comprises a piston 94that pushes said fluid 93 into the mould 81. Said fluid 93 being adaptedto harden to create a medical device adapted to serve as at least oneartificial hip joint surface.

FIG. 24 shows the hip joint in section wherein the medical device 93′ islocated between the acetabulum 8 and the caput femur 5 which has beencreated by the hardening of the fluid 93 adapted to harden. Said medicaldevice is adapted to serve as at least one artificial hip joint surface.The hole in the pelvic bone is preferably sealed with a bone plug 31 ora prosthetic part 98. The mould 81 used to create the medical device 93′has been resorbed by the human body. According to another embodiment themould used to create the medical device 93′ has melted.

FIG. 25a shows the prosthetic part 98 being inserted into a hole 18 inthe pelvic bone 9 from the opposite side from acetabulum 8. According toone embodiment the prosthetic part 98 comprises supporting members 99adapted to correspond with sections 100 of the hole 18 in the pelvicbone 9. After the prosthetic part 98 has been inserted into said hole 18in the pelvic bone 9 it is rotated so that the supporting members 99comes in contact with the pelvic bone 9 and can carry the load placed onthe acetabulum 8 from weight of the human patient through the contactwith the caput femur 5. Said prosthetic part 98 could also be adapted toserve as artificial acetabulum surface 65 according to any of the abovementioned embodiments.

FIG. 25b shows the prosthetic part 98 when rotated to carry the loadplaced on the acetabulum 8 from weight of the human patient through thecontact with the caput femur 5.

FIG. 25c shows the hip joint of a human patient in section wherein theprosthetic part 98 closes the hole 18 in the pelvic bone 9 and carriesthe load placed on the acetabulum 8 from weight of the human patientthrough the contact with the caput femur 5 by means of the supportingmembers 99. The prosthetic part 98 can further be fixated to the pelvicbone 9 by means of bone cement, adhesive, screws, form fitting, welding,sprints, band or some other mechanical connecting member.

FIG. 26a shows the hip joint of a human patient in section wherein boneplug 31 or prosthetic part 98 is attached to the pelvic bone 9 by meansof screws 101 placed from the opposite side from acetabulum 8. Thescrews 101 are possible to place in different angles depending on reachor need for support.

FIG. 26b shows the hip joint of a human patient in section wherein boneplug 31 or prosthetic part 98 is attached to the pelvic bone 9 by meansof a plate 102 at least partly covering said bone plug 31 or prostheticpart 98. According to a first embodiment the plate 102 is attached tothe pelvic bone 9 by means of screws 103 placed from the opposite sidefrom acetabulum 8. However it is also conceivable that said screws 103can be replaced or assisted by bone cement, adhesive, form fitting,welding, sprints, band or some other mechanical connecting member.

FIG. 26c shows the hip joint of a human patient in section wherein twobone plugs 31 or prosthetic parts 98 are attached to the pelvic bone 9by means of a plate 102 at least partly covering said bone plugs 31 orprosthetic parts 98. According to a first embodiment the plate 102 isattached to the pelvic bone 9 by means of screws 103 placed from theopposite side from acetabulum 8. However it is also conceivable thatsaid screws 103 can be replaced or assisted by bone cement, adhesive,form fitting, welding, sprints, band or some other mechanical connectingmember.

FIG. 26d shows the hip joint of a human patient in section wherein twoholes 18 in the pelvic bone has been covered by means of a fluidinjected into said holes 18, through sealing members 104, said fluid 93being adapted to harden. Further more a plate 102 has been provided atleast partly covering said holes 18. According to a first embodiment theplate 102 is attached to the pelvic bone 9 by means of screws 103 placedfrom the opposite side from acetabulum 8. However it is also conceivablethat said screws 103 can be replaced or assisted by bone cement,adhesive, form fitting, welding, sprints, band or some other mechanicalconnecting member. FIG. 66d also shows the provided artificialacetabulum surface 65, and the provided artificial caput femur surface45.

FIG. 27a shows the knee joint wherein an injecting member 92 injects afluid 93 into a mould 81 in the knee joint. The injecting member 92comprises a piston 94 that pushes said fluid 93 into the mould 81. Saidfluid 93 being adapted to harden to create a medical device adapted toserve as at least one artificial knee joint surface.

FIG. 27b shows the knee joint wherein an injecting member 92 injects afluid 93 into a mould 81 in the knee joint through a small hole 18′ in alaparoscopic/arthroscopic method. The injecting member 92 comprises apiston 94 that pushes said fluid 93 into the mould 81. Said fluid 93being adapted to harden to create a medical device adapted to serve asat least one artificial knee joint surface.

FIG. 28 shows a lateral section of the human body wherein an injectingmember 92 injects a fluid into a mould 81 in the hip joint through ahole 18 in the pelvic bone 9 from the opposite side from acetabulum 8.The injecting member penetrating the skin 300 of the human patient in asurgical or laparoscopic method.

FIG. 29 shows the injecting member 92 according to any of theembodiments above, adapted to inject fluid 93 into a mould 81 in the hipjoint or the knee joint. The injecting member 92 could further beadapted to inject material 93 or a fluid 93 into a connecting areabetween the pelvic bone 9 and a prosthetic part, the pelvic bone 9 and abone plug 31 or the caput femur 5 and a prosthetic part. Said injectingmember 92 comprises a container 107 adapted to hold a fluid 93 forinjection. According to a first embodiment said container 107 comprisestwo compartments 108 a,b adapted to hold two different fluids, saidfluids being adapted to harden when mixed. In the embodiment when thecontainer 107 is adapted to hold two fluids, it is conceivable that theinjecting member 105 further comprises a mixing member 109 wherein saidtwo fluids are being mixed before injection. According to a secondembodiment (not shown) said container 107 is adapted to keep said fluidsterile. According to a third embodiment (not shown) said container 107is adapted to keep said fluid cold or hot and according to a fourthembodiment (not shown) said container 107 is adapted to keep said fluidin a dark environment. Furthermore a combination of the above mentionedembodiments is conceivable.

According to another embodiment (not shown) the fluid is adapted toharden through the mixing with a gas. In which case one of the twocompartments is adapted to hold a pressurized gas (such as nitrogen gas)adapted to act as catalyzing agent for the fluid adapted to harden.According to that embodiment the mixing unit 109 is adapted to mix oneliquid and one gas fluid. Said first, second or mixed fluid could alsobe adapted to harden by means of UV-light, thermal change or contactwith a body fluid.

FIG. 30 shows an injecting member 92 wherein the injecting membercomprises a part or section adapted to bend. The instrument could beadapted to bend by means of said injecting member being flexible, shownin FIG. 30, or comprising at least one joint, shown in FIG. 31.

Please note that any embodiment or part of embodiment as well as anymethod or part of method could be combined in any way. All examplesherein should be seen as part of the general description and thereforepossible to combine in any way in general terms.

The invention claimed is:
 1. A surgical or arthroscopic method forproviding an artificial joint surface in a human patient using a mold,said method comprising the steps of: placing at least two trocars in anarea of the patient being located in the proximity of a bone adjacent toa joint, inserting a camera through one of the trocars, inserting atleast one dissecting tool through one of said at least two trocars,dissecting an area of the adjacent bone, creating a hole in saiddissected area, said hole passing through the adjacent bone and into thejoint of the human patient, placing said mold inside of the joint,injecting said mold with a fluid adapted to cure, wherein said mold isadapted to chemically react with the injected fluid such that said moldis resorbed by the human body and/or melts by the injected material,wherein the step of placing said mold inside of the joint is conductedby introducing a mold passing through the hole into the joint, andthereafter conducting the step of injecting said mold with a fluidadapted to cure, also through said hole, and said fluid being adapted tocure serving as artificial joint surface.
 2. The surgical orarthroscopic method according to claim 1, wherein said mold comprises amaterial adapted to chemically react with the injected fluid materialsuch that said mold melts or is resorbed by the human body after havingreceived the injected fluid material and thus served its purpose.
 3. Thesurgical or arthroscopic method according to any one of claims 1 or 2,wherein after said fluid has cured inside of the joint said fluid servesas an artificial joint surface.
 4. The method according to any one ofclaims 1 or 2, wherein said method further comprises the step of heatingsaid fluid to a temperature of more than 40 degrees Celsius fortransforming said fluid from a solid to a fluid, and said injected fluidtransforming to a solid when received in said mold, or heating saidfluid to a temperature of more than 60 degrees Celsius for transformingsaid fluid from a solid to a fluid, and said injected fluid transformingto a solid when received in said mold, or heating said fluid to atemperature of more than 90 degrees Celsius for transforming said fluidfrom a solid to a fluid, and said injected fluid transforming to a solidwhen received in said mold, or heating said material to a temperature ofmore than 200 degrees Celsius for transforming said material into afluid, or heating said fluid to a temperature of more than 400 degreesCelsius for transforming said fluid from a solid to a fluid, and saidinjected fluid transforming to a solid when received in said mold. 5.The method according to claim 4, wherein said fluid is injected withsuch a high temperature that it affects the nerve cells in a resurfacingcontacting surface to damage the nerve cells to reduce pain.
 6. Themethod according to any one of claims 1 or 2 further comprising the stepof: inserting a needle or a tube like instrument into a cavity of thepatient being located in the proximity of a bone adjacent to said joint,using the needle or tube like instrument to fill the cavity with a gas,wherein the at least two trocars are laparoscopic trocars.
 7. The methodaccording to claim 1 or 2, wherein said joint in a human patient is oneof a shoulder joint, an elbow joint, a hip joint, a knee joint or a footjoint.
 8. The method according to claim 7, wherein, if the said joint isa hip joint the step of placing said mold into the hip joint comprisesthe step of introducing said mold through a hole in the pelvic bone or ahole in the femoral bone or a hole in the hip joint capsule, and if saidjoint instead is the knee joint the step of placing said mold into theknee joint comprises the step of introducing said mold through a hole inthe femoral bone or a hole in the tibia bone or a hole in the knee jointcapsule.
 9. The method according to claim 6, wherein the joint is a kneejoint, the knee joint comprising the femoral bone and the tibia bonehaving contacting carrying surfaces carrying weight in the knee joint,the method steps comprise: inserting said needle or said tube likeinstrument into the patient's knee joint, using the needle or tube likeinstrument to fill the knee joint with a gas, placing said at least onearthroscopic camera and said at least one surgical instrument in thepatient's knee joint, dissecting an area of the tibia bone, creating ahole in said dissected area, said hole passing through the tibia boneand into the knee joint of the human patient, introducing a mold throughsaid hole passing into the knee joint, placing said mold between thefemoral bone and the tibia bone, said fluid curing inside of the kneejoint and serving as artificial knee joint surface.
 10. The methodaccording to claim 6, wherein the joint is a hip joint of a humanpatient, the hip joint comprising an acetabulum and a caput femur havingcontacting carrying surfaces carrying weight in the hip joint, themethod steps comprise: inserting said needle or said tube likeinstrument into the patient's abdomen, using the needle or tube likeinstrument to fill the abdomen with a gas, placing at least twolaparoscopic trocars in the patient's abdomen, inserting a camerathrough one of the laparoscopic trocars into the patient's abdomen,inserting at least one dissecting tool through one of said at least twolaparoscopic trocars, dissecting an area of the pelvic bone on theopposite side from the acetabulum, creating a hole in said dissectedarea, said hole passing through the pelvic bone and into the hip jointof the human patient, introducing a mold passing into the hip joint,placing said mold between the acetabulum and the caput femur, said fluidcuring inside of the hip joint and serving as artificial hip jointsurface.
 11. The method according to claim 10, wherein the step ofdissecting an area of the pelvic bone comprises dissecting in at leastone of the following areas: the abdominal cavity, an area betweenperitoneum and the pelvic bone, the pelvic area, and the inguinal area.12. The method according to any one of claims 1 or 2, wherein said moldcomprises an activation material chosen from one of a hyaluronan-basedmaterial, a fibrin-based material, a collagen-based material, achitosan-based material.
 13. The method according to claim 12, whereinsaid fluid adapted to cure comprise hyaluronidase if said mold'sactivation material is hyaluronan-based material, plasmin if said mold'sactivation material is fibrin-based material, collagenase if said mold'sactivation material is collagen-based material, lysozyme if said mold'sactivation material is chitosan-based material, wherein the material ofsaid mold is affected by the injection of the fluid adapted to cure suchthat the mold melts or is resorbed faster than without the injection ofthe corresponding fluid adapted to cure.